Reusable Biopsy Bracket 6154Recalls & reported problems
Protek Medical Products, Inc. · Bracket for Samsung Medison C2-5 Ultrasound Transducers · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841912102020), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2020Failure to Align
HOSPITAL IN (B)(6) REPORTED THAT WHEN PERFORMING A PERCUTANEOUS NEPHROSTOMY, THE BRACKET WAS CLIPPED ONTO THE ULTRASOUND PROBE (IN THE RIGHT DIRECTION, MARKED WITH A VISUAL MARKER). AFTER APPLYING THE GEL AND THE STERILE COVER, THE REFERENCED NEEDLE GUIDE IS POSITIONED. DURING THE GESTURE, WHEN THE NEEDLE WAS VISIBLE ON THE ULTRASOUND MACHINE, IT WAS NOT IN THE AXIS OF THE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10503064 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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